Contezolid Acefosamil Versus Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infection
Overview
The purpose of this study is to determine whether contezolid acefosamil is as safe and effective as linezolid in the treatment of adult patients with acute bacterial skin and skin structure infections
Full Title of Study: “A Phase 2, Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Contezolid Acefosamil Compared to Linezolid Administered Intravenously and Orally to Adult Subjects With Acute Bacterial Skin and Skin Structure Infection”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double (Participant, Investigator)
- Study Primary Completion Date: March 26, 2019
Interventions
- Drug: contezolid acefosamil
- IV and oral contezolid acefosamil given twice a day for 10 to 14 days
- Drug: linezolid 600 mg
- IV and oral linezolid given twice a day for 10 to 14 days
Arms, Groups and Cohorts
- Experimental: contezolid acefosamil
- contezolid acefosamil 1500 mg IV x 1 dose, followed by 1000 mg IV q12h for at least 3 total IV doses, followed by 1300 mg PO q12h for 10 to 14 days
- Active Comparator: linezolid
- linezolid 600 mg IV q12h for at least 3 total IV doses, followed by 600 mg PO q12h for 10 to 14 days
Clinical Trial Outcome Measures
Primary Measures
- Early Clinical Response at the Early Assessment Visit (ITT Population)
- Time Frame: 48 to 72 hours after the start of study drug
- Early clinical response assessment based on the electronic case report form (eCRF) data at Early Assessment (48-72 hours after start of study drug) where a successful response (i.e., “responder”) was defined as a reduction in primary ABSSSI lesion size ≥20% compared to baseline, and the subject did not receive a non-protocol specified systemic antibacterial agent with activity against Gram-positive organisms for the treatment of ABSSSI and did not die of any cause up to Early Assessment.
Participating in This Clinical Trial
Inclusion Criteria
- Patients with systemic signs of infection diagnosed with acute bacterial skin and skin structure infection (ABSSSI) – Diagnosed with cellulitis/erysipelas, major cutaneous abscess, or wound infections Exclusion Criteria:
- Uncomplicated skin infections – Severe sepsis or septic shock – ABSSSI solely due to Gram-negative pathogens – Prior systemic antibiotics within 96 hours of randomization
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- MicuRx
- Provider of Information About this Clinical Study
- Sponsor
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